Risk Manager / FMEA Specialist

Primary Function: Owns risk management documentation and facilitates integration of risk-related updates within the DHF, including FMEA updates and risk matrix revisions.

Key Responsibilities:

· Update or contribute to Design and Process FMEAs in alignment with DHF updates

· Maintain and revise risk management files and risk traceability matrices

· Collaborate with onshore and offshore teams to ensure risks are adequately mitigated and documented

· Participate in or facilitate risk review sessions

· Ensure consistency with ISO 14971 and internal risk management processes

Location Requirement: 📍 Candidate must be based in Pune, India or willing to relocate.

Working Hours Requirement: ⏰ Candidate must be available to work until 12:00 PM Eastern Time (ET) to coordinate with US-based team members.

Qualifications:

· 4–7 years in Risk Management or Regulatory Engineering for medical devices

· Hands-on experience with FMEA (Design & Process), hazard analysis, and risk documentation

· Deep understanding of ISO 14971 and MDR risk requirements

· Experience with team-based risk sessions and traceability documentation